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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD LUER-LOK¿ TIP SYRINGE; PISTON SYRINGE
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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD LUER-LOK¿ TIP SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 309653
Device Problem Moisture or Humidity Problem (2986)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/16/2023
Event Type  malfunction  
Event Description
It was reported that an unspecified amount of bd luer-lok¿ tip syringes' packaging units had condensation inside them.The following information was provided by the initial reporter: "having condensation inside the sealed packages.No impact as the syringes were not used.".
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Manufacturer Narrative
Investigation summary: a device history record review was completed by our quality engineer team for provided material number 309653 and lot number 2362064.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.
 
Event Description
It was reported that an unspecified amount of bd luer-lok¿ tip syringes' packaging units had condensation inside them.The following information was provided by the initial reporter: "having condensation inside the sealed packages.No impact as the syringes were not used.".
 
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Brand Name
BD LUER-LOK¿ TIP SYRINGE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer (Section G)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key16679215
MDR Text Key313015807
Report Number1911916-2023-00204
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903096534
UDI-Public00382903096534
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K110771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309653
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/11/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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